The FDA and Emergency Contraception: One Year After the Decision

03.19.10 - On March 23, 2009, the Center scored a major victory when a federal court ruled that the U.S. Food and Drug Administration had put politics before women’s health when it decided to limit access to emergency contraception.

In its decision, the Court found that the FDA “acted in bad faith and in response to political pressure” and ordered the agency to go back and revisit the age and behind-the-counter restrictions to emergency contraception.

Today, emergency contraception is available without a prescription, but only for women age 17 and older. Pharmacies and clinics must keep it behind the counter and anyone seeking to buy it must show government issued identification proving their age in order to buy it without a prescription.

These intrusive restrictions, unprecedented for drugs with over-the-counter status, make it harder and more stigmatizing for consumers to get the contraception during its most effective window.

Scientists and medical experts, including the FDA’s own scientific review panel, agree there are no medical grounds for denying young women access to emergency contraception.
Expanding access to emergency contraception is the best decision for women’s health. The FDA has had a full year to review its decision to restrict access to emergency contraception and cannot continue hiding behind procedural delays.

Background

The Center sued the FDA in 2005 for failing to grant over-the-counter status to emergency contraception (a.k.a Plan B) against the advice of its scientific experts and in violation of its own procedures and regulations. In 2006, the FDA agreed to make Plan B available without a prescription, but only to women 18 and over and only behind the pharmacy counter.

The Center continued to pursue its lawsuit, Tummino v. von Eschenbach, to ensure that Plan B would be granted true over-the-counter status and made available to all women, including young women who might benefit most from this form of contraception.

In its decision, the Court found that the FDA “acted in bad faith and in
response to political pressure,” “departed in significant ways from the
agency’s normal procedures,” and engaged in “repeated and unreasonable
delays.” In addition, the court found that the FDA’s justification for
denying over-the-counter access to 17-year-olds “lacks all credibility,”
and was based on “fanciful and wholly unsubstantiated ‘enforcement’
concerns.”

The Center for Reproductive Rights filed the lawsuit on behalf of
the Association of Reproductive Health Professionals (ARHP), National
Latina Institute for Reproductive Health, individuals from a grassroots
advocacy group, the Morning-After Pill Conspiracy, and parents who seek
over-the-counter access for their daughters.

Some Facts

The FDA has had a year to remove the politically motivated age restriction and it has not done so.

Medical and scientific consensus provides no rationale for age restrictions on Plan B.

The Bush Administration did not want young women to have access to Plan B — an innovative, proven, and safe contraception.

More than 60 medical
and citizen groups signed the Center's Citizen's Petition to the FDA stating that emergency contraception was safe, efficacious, and easy to administer — all three factors required by the FDA for over-the-counter medications.